Please do not apply if you do not have experience with:
Cell Therapy
Managing Direct Reports
At least 7 years of pharma / biotech industry experience and 5+ years of management experience
No Third Party Inquiries Please
Our Biopharma client is seeking a Senior Manager, Quality Management, to join the Quality Assurance and Product Quality organization. The candidate should have substantial experience in both clinical and commercial operations within a reputable pharmaceutical, biotechnology, advanced therapy, or cell therapy company (preferred experience in advanced therapy or cell therapy). The candidate should be experienced with managing department initiatives and yearly objectives to drive improvements to processes, systems, procedures, ways of working, training ownership and review, and cross-functional collaboration. S/he will be an integral part of the department working with key stakeholders within the department covering Quality Operations, Quality Engineering, External Quality, and Product Quality as needed. The candidate should have experience coordinating and managing Quality Councils for both internal and external operations in support of periodic Quality Management Reviews, and be adept at coordination of presentation materials with impacted departments.
S/he will also be assigned periodic improvement projects both directly or indirectly to help department achieve yearly goals and improvements as assigned. The candidate will have knowledge of and experience with quality systems, document management systems, specification management strategies, annual product quality reviews, and change control. The candidate will serve as an influential change agent that is able to work collaboratively and cross-functionally with both internal and external stakeholders and management to support cross-program and cross-site alignment.
The successful candidate will report to the Vice President, Quality Assurance and Product Quality and will support the department Quality leadership team as required.
Essential Functions and Responsibilities
Must have a strong Quality mindset with knowledge of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA, etc.) requirements for cell therapies and biologics
Knowledge of risk management principles and their implementation into routine Quality activities and/or strategies.
Manage the preparation of information, presentation compilation, follow-up on action items, and management of attendees and distribution of the Quality Council meetings for internally and externally manufactured Drug Product and iPBMCs.
Manage the preparation of information and management of attendees and distribution of the QA & PQ Monthly group meeting and coordinate with Leadership team members on content, format, guest speakers, meeting minutes, and action item follow-up.
Must be able to recognize problems and effectively communicate and collaborate with stakeholders to assess and document risks, implement mitigations, and escalate within and across project teams and to management.
Must manage problems of diverse scope and demonstrate ability to translate complex issues in a concise manner.
Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
Ensure all functions and SMEs are aware of and are following the Quality Council review process within the Quality Management System.
Must be able to recognize problems and effectively communicate and collaborate with stakeholders to assess and document risks, implement mitigations, and escalate within and across project teams and to management.
Communicates and collaborates within function and with cross-functional stakeholders with clarity and transparency.
Operates at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
Performs duties with a high level of autonomy, accountability, and ownership and with minimal supervision and oversight
Adheres to client's core values, policies, procedures, and business ethics.
Supports and performs other activities as assigned.
Manage development and generation of Quality Metrics for the department.
May review and/or approve SOP revisions.
Drives continuous improvement by seeking out and implementing operational excellence projects and activities.
Perform miscellaneous duties as assigned.
Preferred Education, Skills, and Knowledge
Bachelor's Degree in Science, Engineering, or a related technical discipline.
Minimum seven years of experience in a regulated industry, with at least 5 years of supervisory experience.
Proficient knowledge of cGMP regulations.
Perform routine activities with minimal oversights.
Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
Extremely detail oriented with strong technical and people skills.
Knowledge of MasterControl is preferred.
High level of accountability and ownership.
Demonstrate a sense of urgency ability to recognize time sensitivity.
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Successfully interface with multidisciplined teams.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Physical Demands and Activities Required
Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps.
Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
Must be able to communicate with others to exchange information.